Comparison of Versant HBV DNA 3.0 and COBAS AmpliPrep-COBAS TaqMan assays for hepatitis B DNA quantitation: Possible clinical implications

Journal of Virological Methods

Volumn 146, Issue 1-2, 2007, Pages 274-280

  Garbuglia, A R ^a   Angeletti, C ^a   Lauria, F N ^a   Zaccaro, P ^a   Cocca, A M ^a   Pisciotta, M ^a   Solmone, M ^a   Capobianchi, M R ^a  

^a NATIONAL INSTITUTE FOR INFECTIOUS DISEASES L SPALLANZANI   (Italy)

Author keywords

Assay performance; bDNA; Diagnostic accuracy; HBV DNA; Real time PCR

Indexed keywords

VIRUS DNA;

ARTICLE; ASSAY; BLOOD DONOR; CONTROLLED STUDY; GENE MUTATION; HEPATITIS B VIRUS; HUMAN; PRIORITY JOURNAL; STRUCTURAL GENE; WORLD HEALTH ORGANIZATION;

ADULT; DNA, VIRAL; FEMALE; HEPATITIS B; HEPATITIS B VIRUS; HUMANS; MALE; MIDDLE AGED; POLYMERASE CHAIN REACTION; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; VIRAL LOAD;

HEPATITIS B VIRUS;

EID: 35648971593     PISSN: 01660934     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jviromet.2007.07.005     Document Type: Article

References (31)

1. Allice T., Cerutti F., Pittaluga F., Varetto S., Gabella S., Marzano A., Franchello A., Colucci G., and Ghisetti V. COBAS AmpliPrep-COBAS TaqMan Hepatitis B Virus (HBV) test: a novel automated real-time PCR assay for quantitation of HBV DNA in plasma. J. Clin. Microbiol. 45 (2007) 828-834
2. Bartholomeusz A., and Locarnini S.A. Antiviral drug resistance: clinical consequences and molecular aspects. Semin. Liver Dis. 26 (2006) 162-170
3. Berger A., Preiser W., and Doerr H.W. The role of viral load determination for management of human immunodeficiency virus, hepatitis B virus and hepatitis C infection. J. Clin. Virol. 20 (2001) 23-30
4. Bland J.M., and Altman D.G. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1 (1986) 307-310
5. Bossuyt P.M., Irwig L., Craig J., and Glasziou P. Comparative accuracy: assessing new tests against existing diagnostic pathways. BMJ 332 (2006) 1089-1092
6. Bossuyt P.M., Reitsma J.B., Bruns D.E., Gatsonis C.A., Glasziou P.P., Irwig L.M., Moher D., Rennie D., de Vet H.C., and Lijmer J.G. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Standards for Reporting of Diagnostic Accuracy. Clin. Chem. 49 (2003) 1-6
7. Chu C. Quantitative serum HBV DNA level during different stage of chronic hepatitis B infection. Hepatology 36 (2002) 1408-1415
8. EASL Jury, 2003. EASL International Consensus Conference on Hepatitis B. Geneva, Switzerland, 13-14 September 2002. Consensus statement. J. Hepatol. 39, S3-S25.
9. Hadziyannis S.J., and Papatheodoridis G.V. Hepatitis B e antigen-negative chronic hepatitis B: natural history and treatment. Semin. Liver Dis. 26 (2006) 130-141
10. Ho S.K., Yam W.C., Leung E.T., Wong L.P., Leung J.K., Lai K.N., and Chan T.M. Rapid quantitation of hepatitis B virus DNA by real-time PCR using fluorescent hybridization probes. J. Med. Microbiol. 52 (2003) 397-402
11. Hochberger S., Althof D., Gallegos deSchrott R., Nachbaur N., Roch H., and Leying H. Fully automated quantitation of hepatitis B virus (HBV) DNA in human plasma by the COBAS AmpliPrep/COBAS TaqMan system. J. Clin. Virol. 35 (2006) 373-380
12. Hoofnagle J.H. Alfa-interferon therapy of chronic hepatitis B. Current status and recommendations. Hepatology 11 (1990) 100-107
13. Hui C.K., Bowden S., Zhang H.Y., Wong A., Lewin S., Rousseau F., Mommeja-Marin H., Lee N.P., Luk J.M., Locarnini S., Leung N., Naoumov N.V., and Lau G.K. Comparison of real-time PCR assays for monitoring serum hepatitis B virus DNA levels during antiviral therapy. J. Clin. Microbiol. 44 (2006) 2983-2987
14. Jardi R., Rodriguez F., Buti M., Costa X., Cotrina M., Valdes A., Galimary R., Esteban R., and Guardia J. Quantitative detection of hepatitis B virus DNA in serum by a new rapid real-time fluorescence PCR assay. J. Viral. Hepatol. 8 (2001) 465-471
15. Kessler H.H., Stelzl E., Daghofer E., Santner B.I., Marth E., Lackner H., and Stauber R.E. Semiautomated quantitation of hepatitis B virus DNA in a routine diagnostic laboratory. Clin. Diagn. Lab. Immunol. 7 (2000) 853-855
16. Lok A.S., Heathcote E.J., and Hoofnagle J.H. Management of hepatitis B: 2000 Summary of a workshop. Gastroenterology 120 (2001) 1828-1853
17. Lok A.S., McMahon B.J., Practice Guidelines Committee, and American Association for the study of Liver Diseases (AASLD). Chronic hepatitis B: update of recommendations. Hepatology 39 (2004) 857-861
18. Lok A.S., and McMahon B.J. Chronic hepatitis B. Hepatology 45 (2007) 507-539
19. Marin I.J., Poljak M., Seme K., Brinovec V., Maticic M., Meglic-Volkar J., Lesnicar G., and Gradisek P. Comparative evaluation of three commercial assays for quantitative measurement of hepatitis B virus DNA in serum samples. Hepatogastroenterology 49 (2002) 1390-1394
20. Medici M.C., Aloisi A., Martinelli M., Abelli L.A., Casula F., Vacalvi P., Dettori G., and Chezzi C. HBV genotypes and antiviral-resistant variants in HBV infected subjected in Northern Italy. New Microbiol. 29 (2006) 63-67
21. Mori K., Minami M., Kirishima T., Kunimoto K., Okita M., Nakayama M., Makiyama A., Nakajima T., Yasui K., Itoh Y., and Okanoue T. Prediction of breakthrough hepatitis due to Lamivudine-resistant hepatitis B virus by a sensitive semiquantitative assay using peptide nucleic acids. Intervirology 49 (2006) 274-280
22. Niitsuma H., Ishii M., Masahito M., Kobayashi K., and Toyota T. Low level hepatitis B viremia detected by polymerase chain reaction accompanies the absence of HBe antigenemia and hepatitis B virus carriers. Am. J. Gastroenterol. 92 (1997) 119-123
23. Paik Y.H., Han K.H., Hong S.P., Lee H.W., Lee K.S., Kim S.O., Shin J.E., Ahn S.H., Chon C.Y., and Moon Y.M. The clinical impact of early detection of the YMDD mutant on the outcomes of long-term lamivudine therapy in patients with chronic hepatitis B. Antiviral. Ther. 11 (2006) 447-455
24. Pawlotsky J.M. Molecular diagnosis of viral hepatitis. Gastroenterology 122 (2002) 1554-1568
25. Perrillo R.P., Gish R.G., Peters M., Keefe E.B., Alberti A., Buti M., Cooksley W.G., Fried M.W., Hadziyannis S.J., Liaw Y.F., Naoumov N.V., Schiff E.R., Thio C.L., Tsai N., and Schalm S. Chronic hepatitis B: a critical appraisal of current approaches to therapy. Clin. Gastroenterol. Hepatol. 4 (2006) 233-248
26. Ronsin C., Pillet A., Bali C., and Denoyel G.A. Evaluation of the COBAS AmpliPrep-total nucleic acid isolation-COBAS TaqMan hepatitis B virus (HBV) quantitative test and comparison to the Versant HBV DNA 3.0 assay. J. Clin. Microbiol. 44 (2006) 1390-1399
27. Song B.C., Suh D.J., Lee H.C., Chung Y.H., and Lee Y.S. Hepatitis B e antigen seroconversion after lamivudine theraphy is not durable in patients with chronic hepatitis B in Korea. Hepatology 32 (2000) 803-806
28. Tedder R.S., Ijaz S., Gilbert N., Barbara J.A., Corden S.A., Gilson R.J., and Boxall E.H. Evidence for a dynamic host-parasite relationship in e-negative hepatitis B carriers. J. Med. Virol. 68 (2002) 505-512
29. ter Borg F., and Jones E.A. Prediction of hepatic inflammatory activity in hepatitis B. Lancet 352 (1998) 1555
30. Werle-Lapostolle B., Bowden S., Locarnini S., Wurstorn K., Petersen J., Lau G., Trepo C., Marcellin P., Goodman Z., Delaney IV W.E., Xiong S., Brosgart C.L., Chen S.S., Gibbs C.S., and Zoulim F. Persistence of cccDNA during the natural history of chronic hepatitis B and decline during adefovir dipivoxil therapy. Gastroenterology 126 (2004) 1750-1758
31. Yao J.D., Beld M.G., Oon L.L., Sherlok C.H., Germer J., Menting S., Se Thoe S.Y., Merrick L., Ziermann R., Surtihadi J., and Hnatyszyn H.J. Multicenter evaluation of the Versant hepatitis B virus DNA 3.0 assay. J. Clin. Microbiol. 42 (2004) 800-806